Data Management for Clinical Research

This page contains information and links for Division of Microbiology and Infectious Diseases (DMID) staff and clinical site investigators concerning the handling of clinical research data.

DMID Policies

• Distribution of Safety Information
• Sharing Results with Study Participants
• Distribution of Clinical Research Endpoint Data
• Expanded Distribution of Clinical Research Endpoint Data
• Unblinding Individual Participants in DMID Clinical Research
• Data Management
• Guidance on Terminology of Biospecimens and Data
• Independent Data and Safety Oversight for DMID Clinical Research
• Statistical Analysis Plan
• Use of DMID Contract Statistical and Data Coordinating Centers (SDCC) for DMID Protocols

EMMES-Statistical and Data Coordinating Center (SDCC) for many DMID-sponsored contract clinical trials. (authorized users only)

​Additional Information

• Clinical Research Selected References - on this page you will find selected references for:
  • Food and Drug Administration
    • 21 Code of Federal Regulation Part11 for regulation on electronic data
    • 21 CFR 312 for IND reporting requirements
    • 21CFR 812 for IDE reporting requirements
    • Electronic Source Documentation in Clinical Investigations- Draft
    • FDA Guidance for Sponsors, Clinical Investigators and IRBs: Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials
  • Good Clinical Practices for International Conference on Harmonisation (ICH) Guidance's
    • Good Clinical Practices (GCP) E6
    • Clinical Safety E1-2F
    • Clinical Study Reports E3
    • Guidance on General Considerations for Clinical Trials E8
    • Statistical Principles for Clinical Trials E-9
    • Quality Risk Management Q9
• DMID Training Modules - on this page you will find training opportunities for:
  • Electronic Data Entry (authorized users only) can be found under …  [Mason, I didnt see anything about Electronic Data Entry on the page we are linking to. Can we either add it to a list on the training modules page or link directly to the training that has this even if its for authorized users?]
• Data Policy and Guidance - on this page you will find:
  • NIH Data Sharing Policies
  • Guidance for NIAID Researchers
  • Resources for Sharing and Accessing Data
  • Data Sharing Resources and Training